CN106714709B - Method of attaching a mesh to a coated ring member of a surgical snare device - Google Patents
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- A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
- A61B17/221—Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions
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- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
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- A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
- A61B17/221—Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions
- A61B2017/2212—Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions having a closed distal end, e.g. a loop
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Abstract
本文提供一种将网附接到环构件的方法,所述方法包括用层覆盖线;操纵线和层以形成环构件,其中环构件具有形状,将网放置在环构件上,其中网的部分延伸超过环构件的周边,将热转移到层使其部分地熔化并变胶粘,允许网与胶粘层熔合并且在冷却时形成稳固结合,以及修整网的延伸超过环固件的周边的部分。通过所述方法形成的摘取装置包括环构件和附接的网,其位于管形护套内并且可纵向移动。环构件和网被用于捕捉目标物体,并且部分地缩回以移除物体。
Provided herein is a method of attaching a mesh to a loop member, the method comprising covering a wire with a layer; manipulating the wire and the layer to form a loop member, wherein the loop member has a shape, placing the mesh on the loop member, wherein portions of the mesh Extending beyond the perimeter of the ring member, transferring heat to the layer to partially melt and become tacky, allowing the mesh to fuse with the adhesive layer and form a strong bond upon cooling, and trim the portion of the mesh that extends beyond the perimeter of the loop fastener. The harvesting device formed by the method includes a ring member and an attached mesh that is positioned within the tubular sheath and is longitudinally movable. Ring members and nets are used to capture the target object and partially retract to remove the object.
Description
相关申请的交叉引用CROSS-REFERENCE TO RELATED APPLICATIONS
本申请的优先权依赖于2014年9月19日提交的发明名称为“Method of Attachinga Mesh to a Coated Loop Member of a Surgical Snare Device”的No.62/052,538美国专利临时申请和2015年5月17日提交的发明名称为“Method of Attaching a Mesh to aCoated Loop Member of a Surgical Snare Device”的No.62/162,786美国专利临时申请。The priority of this application is based on U.S. Patent Provisional Application No. 62/052,538 filed on September 19, 2014 and entitled "Method of Attachinga Mesh to a Coated Loop Member of a Surgical Snare Device" and on May 17, 2015 U.S. Patent Provisional Application No. 62/162,786 for the invention titled "Method of Attaching a Mesh to a Coated Loop Member of a Surgical Snare Device" filed on 19 March.
本文通过引用将上述申请以其整体并入。The above application is incorporated herein by reference in its entirety.
技术领域technical field
本申请一般地涉及外科器械。更特别的,本说明书涉及外科勒除器(surgicalsnare)装置,其被用于从身体内腔移除物体,其中网或网状物被熔合和结合有外科勒除器装置的带涂层的环构件。This application generally relates to surgical instruments. More particularly, the present specification relates to surgical snare devices used to remove objects from body lumens in which a mesh or mesh is fused and incorporated with a coated ring of the surgical snare device member.
背景技术Background technique
用于抓持外物并从身体器官或腔体移除外物的现有外科装置包括机械致动钳子、机械致动勒除器或机械致动篮子。在内窥镜、荧光或直接可视化下,这些外科装置的每个可以被定位在身体中。Existing surgical devices for grasping and removing foreign objects from bodily organs or cavities include mechanically actuated forceps, mechanically actuated snare or mechanically actuated baskets. Each of these surgical devices can be positioned in the body under endoscopy, fluorescence or direct visualization.
机械致动勒除器包括柔性网体构件的组件,其被安装在线环上,被封闭在护套中。线环能延伸超过护套以自动伸展为成形的开口,结果,还将附接/安装的网体构件打开成捕捉口袋。开口的尺寸被线的前进超过护套的端部的长度控制。在使用中,在将勒除器定位成邻近物体后,线被前进超过护套的端部直到形成大于物体的环为止。环然后被定位直到网体构件和环的平面包围物体为止。护套然后被前进并且线被缩回,从而环和网体构件围住并诱捕/困住物体。The mechanically actuated snare includes an assembly of flexible mesh members mounted on a wire loop enclosed in a sheath. The wire loop can extend beyond the sheath to automatically expand into a shaped opening and, as a result, also open the attached/mounted mesh member into a capture pocket. The size of the opening is controlled by the length of the advancement of the wire beyond the end of the sheath. In use, after positioning the snare adjacent the object, the wire is advanced over the end of the sheath until a loop is formed that is larger than the object. The ring is then positioned until the mesh member and the plane of the ring surround the object. The sheath is then advanced and the wire retracted so that the loop and mesh members enclose and trap/trapp the object.
通常通过沿着线环的周边编织和/或通过使用夹子或小圈,将网体构件附接到线环。当将环撤回到护套中时,为了绕物体关闭环,将网体构件连接到环的材料线股和在一些情形中包括网体构件的材料可以沿着环滑动并且在环的远侧端处集中。网体材料还可以聚在一起并介于物体和环的远侧端之间。类似地,夹子或小圈的存在还妨碍捕捉物体并且使得捕捉物体更困难和耗时,其中网体构件通过夹子或小圈结合到环。The mesh member is attached to the wire loop, typically by weaving along the perimeter of the wire loop and/or by using clips or small loops. To close the loop around an object when the loop is withdrawn into the sheath, the strands of material connecting the mesh member to the loop, and in some cases the material comprising the mesh member, can slide along the loop and at the distal end of the loop concentrated. The mesh material may also come together and be interposed between the object and the distal end of the ring. Similarly, the presence of clips or small loops through which the mesh member is bonded to the loop also hinders and makes it more difficult and time consuming to capture objects.
因此,本领域需要一种将网体构件、网或网状物附接或连接到外科勒除器装置的环构件的改进的方法,使得其不妨碍手术。Accordingly, there is a need in the art for an improved method of attaching or connecting a mesh member, mesh or mesh to a ring member of a surgical snare device such that it does not interfere with surgery.
发明内容SUMMARY OF THE INVENTION
连同系统、工具和方法描述和说明以下实施例及其方面,这些系统、工具和方法是示例性的和说明性的,而不限制范围。本申请公开多个实施例。The following embodiments and aspects thereof are described and illustrated in conjunction with systems, tools, and methods, which are exemplary and explanatory and not limiting in scope. This application discloses various embodiments.
本说明书公开一种将网附接到环构件的方法,该方法包括以下步骤:操纵线以形成具有形状的环构件,其中所述线是第一材料的;施加粘结剂层到所述环构件;将所述网放置在所述环构件上,其中所述网是第二材料的,其中所述网至少部分地覆盖所述环构件的周边,并且其中所述网的部分延伸超过所述环构件的周边;在所述网被保持在所述环构件上的同时,使所述粘结剂暴露到紫外线辐射;允许所述网与所述粘结剂结合;以及修整所述网的延伸超过所述环构件的所述周边的所述部分,其中,所述环构件和所附接的网通过缩回到护套的内腔中是可收缩的并且当被延伸出所述护套时可伸展到所述形状。The present specification discloses a method of attaching a mesh to a loop member, the method comprising the steps of: manipulating a wire to form a loop member having a shape, wherein the wire is of a first material; applying a layer of adhesive to the loop a member; placing the mesh on the ring member, wherein the mesh is of a second material, wherein the mesh at least partially covers the perimeter of the ring member, and wherein a portion of the mesh extends beyond the a perimeter of a ring member; exposing the adhesive to ultraviolet radiation while the web is held on the ring member; allowing the web to bond with the adhesive; and trimming the extension of the web the portion beyond the perimeter of the ring member, wherein the ring member and attached mesh are collapsible by retracting into the lumen of the sheath and when extended out of the sheath Stretchable to the shape.
所述环构件的所述形状可以是椭圆形、圆形、泪滴形、正方形、长方形、四边形或多边形中的任一种。The shape of the ring member may be any of oval, circular, teardrop, square, rectangular, quadrilateral or polygonal.
环可以具有沿着经过环构件的中心的纵向轴线的第一尺寸和沿着另一轴线的第二尺寸,所述另一轴线垂直于纵向轴线并且还经过环构件的中心。第一尺寸可以长于所述第二尺寸。可选地,所述第一尺寸范围从30至70厘米并且所述第二尺寸范围从15至40厘米。可替选地,所述第一尺寸等于所述第二尺寸。还可替选地,所述第一尺寸小于所述第二尺寸。The ring may have a first dimension along a longitudinal axis passing through the center of the ring member and a second dimension along another axis perpendicular to the longitudinal axis and also passing through the center of the ring member. The first dimension may be longer than the second dimension. Optionally, the first dimension ranges from 30 to 70 centimeters and the second dimension ranges from 15 to 40 centimeters. Alternatively, the first dimension is equal to the second dimension. Also alternatively, the first dimension is smaller than the second dimension.
所述线的所述第一材料可以是镍钛诺、钢或不锈钢中的至少一种。The first material of the wire may be at least one of Nitinol, steel or stainless steel.
所述网的第二材料可以是聚合的。可选地,所述网的第二材料可以是尼龙、PET或聚醚酰胺中的至少一种。The second material of the mesh may be polymeric. Optionally, the second material of the mesh may be at least one of nylon, PET or polyetheramide.
在结合后,网可以在环构件的中心处具有袋。After bonding, the mesh may have pockets at the center of the ring members.
本说明书还公开一种摘取装置,其包括:柔性线环;结合材料,所述结合材料被层设在所述线环上;网,所述网被结合到所述结合材料以建立具有被所述线环界定的开口的网状物,其中通过加热所述结合材料到轻微粘性的、部分湿的、或者粘性的状态、将所述网的外侧边缘放置在所述结合材料上、以及允许所述结合材料冷却的过程,所述网已经被固定地结合到所述结合材料;和管形护套,所述管形护套包括伸长本体、近侧端、远侧端和在其内的内腔,其中,通过操纵位于所述管形护套的所述近侧端的传递连杆,具有结合的网的所述柔性线环通过在所述管形护套的所述远侧端的开口而可缩回到所述内腔中、并且可延伸出所述内腔。The present specification also discloses an extraction device comprising: a flexible wire loop; a binding material, the binding material being layered on the wire loop; a net, the net being bound to the binding material to establish a an open mesh bounded by the wire loop wherein the outside edge of the mesh is placed on the binding material by heating the binding material to a slightly tacky, partially wet, or tacky state, and allowing the process of cooling the bonding material to which the mesh has been fixedly bonded; and a tubular sheath comprising an elongated body, a proximal end, a distal end, and a tubular sheath therein the lumen, wherein, by manipulating a transfer link located at the proximal end of the tubular sheath, the flexible wire loop with the bound mesh passes through the opening at the distal end of the tubular sheath Rather, it is retractable into the lumen and extendable out of the lumen.
本说明书还公开一种将网附接到环构件的方法,所述方法包括以下步骤:以第二材料的层涂覆第一材料的线;操纵所述线和所述层以形成所述环构件,其中所述环构件具有形状并且其中所述环构件具有沿着经过所述环构件的中心的纵向轴线的第一尺寸和沿着另一轴线的第二尺寸,所述另一轴线垂直于所述纵向轴线并且还经过所述环构件的所述中心;将所述网放置在所述环构件上,其中所述网是第三材料的,其中所述网至少部分地覆盖所述环构件的周边,并且其中所述网的部分延伸超过所述环构件的周边;在将所述网保持在所述环构件上的同时,将热转移到所述层使得所述第二材料部分地熔化并变成胶粘的、轻微粘性的或部分湿的;允许所述网沿着所述环构件的周边与所述层的所述部分熔化且胶粘的第二材料结合在一起,并且在冷却时形成稳固的结合;以及修整所述网的延伸超过所述环构件的所述周边的所述部分,其中,所述环构件和所附接的网被构造成通过缩回到护套的内腔中是可收缩的并且当被延伸出所述护套时可伸展到所述形状。This specification also discloses a method of attaching a mesh to a ring member, the method comprising the steps of: coating a wire of a first material with a layer of a second material; manipulating the wire and the layer to form the ring member, wherein the ring member has a shape and wherein the ring member has a first dimension along a longitudinal axis passing through a center of the ring member and a second dimension along another axis perpendicular to the the longitudinal axis and also passing through the center of the ring member; placing the mesh on the ring member, wherein the mesh is of a third material, wherein the mesh at least partially covers the ring member and wherein portions of the mesh extend beyond the perimeter of the ring member; transferring heat to the layer while retaining the mesh on the ring member partially melts the second material and become tacky, slightly tacky, or partially wet; allowing the web to bond with the partially melted and tacky second material of the layer along the perimeter of the ring member, and upon cooling and trimming the portion of the mesh extending beyond the perimeter of the ring member, wherein the ring member and attached mesh are configured to retract into the sheath by retracting The cavity is collapsible and expandable to the shape when extended out of the sheath.
所述环构件的所述形状可以是椭圆形、圆形、泪滴形、正方形、长方形、四边形和多边形中的任一种。The shape of the ring member may be any of oval, circular, teardrop, square, rectangular, quadrilateral and polygonal.
可选地,所述第一尺寸长于所述第二尺寸。还可选地,所述第一尺寸范围从30至70厘米并且所述第二尺寸范围从15至40厘米。可替选地,所述第一尺寸等于所述第二尺寸。还可替选地,所述第一尺寸小于所述第二尺寸。Optionally, the first dimension is longer than the second dimension. Also optionally, the first dimension ranges from 30 to 70 centimeters and the second dimension ranges from 15 to 40 centimeters. Alternatively, the first dimension is equal to the second dimension. Also alternatively, the first dimension is smaller than the second dimension.
所述线的所述第一材料可以是镍钛诺、钢或不锈钢中的至少一种。可选地,所述层的第二材料是聚合的。还可选地,所述层的第二材料是以下项中的至少一种:尼龙、聚醚酰胺或PET。The first material of the wire may be at least one of Nitinol, steel or stainless steel. Optionally, the second material of the layer is polymeric. Also optionally, the second material of the layer is at least one of the following: nylon, polyetheramide or PET.
可选地,所述网的第三材料是聚合的。还可选地,所述网的第三材料可以是尼龙或PET中的至少一种。Optionally, the third material of the mesh is polymeric. Also optionally, the third material of the mesh may be at least one of nylon or PET.
所述层可以被涂覆在所述线上。The layer may be coated on the wire.
可选地,所述层包括中空管,所述线被插入到所述中空管中。Optionally, the layer comprises a hollow tube into which the wire is inserted.
可选地,所述网具有的形状近似于所述环构件的所述形状。Optionally, the mesh has a shape that approximates the shape of the ring member.
通过加热所述线,热被转移到所述层的所述第二材料。使用外部电源来对线进行电加热。在将所述网保持在所述环构件上的同时,通过加热所述环构件来将热转移到所述层的所述第二材料。可选地,通过将所述环构件暴露到热空气来加热所述环构件,其中所述热空气具有在120至180℃范围内或者在所述第二材料的熔化温度范围内的温度。By heating the wire, heat is transferred to the second material of the layer. Use an external power source to electrically heat the wire. Heat is transferred to the second material of the layer by heating the ring member while maintaining the web on the ring member. Optionally, the ring member is heated by exposing the ring member to hot air, wherein the hot air has a temperature in the range of 120 to 180°C or in the range of the melting temperature of the second material.
可选地,所述层具有范围从0.05mm到0.6mm的厚度。Optionally, the layer has a thickness ranging from 0.05mm to 0.6mm.
在结合后,网可以在环构件的中心处具有袋。After bonding, the mesh may have pockets at the center of the ring members.
本说明书还公开一种将网附接到环构件的方法,该方法包括以下步骤:操纵线以形成成形的线,其中所述线是第一材料的;以第二材料的层覆盖所述成形的线,以形成所述环构件;将所述网放置在所述环构件上,其中所述网是第三材料的,其中所述网至少部分地覆盖所述环构件的周边,并且其中所述网的部分延伸超过所述环构件的周边;在所述网被保持在所述环构件上的同时,将热转移到所述层,使得所述第二材料部分地熔化并变成胶粘的、轻微粘性的或者部分湿的;允许所述网与所述层的部分熔化的且胶粘的第二材料结合;以及修整所述网的延伸超过所述环构件的所述周边的所述部分,其中,所述环构件和所附接的网通过缩回到护套的内腔中是可收缩的并且当被延伸出所述护套时可伸展到所述形状。The present specification also discloses a method of attaching a mesh to a ring member, the method comprising the steps of: manipulating a wire to form a shaped wire, wherein the wire is of a first material; covering the forming with a layer of a second material the wire to form the ring member; placing the mesh on the ring member, wherein the mesh is of a third material, wherein the mesh at least partially covers the perimeter of the ring member, and wherein the A portion of the mesh extends beyond the perimeter of the ring member; while the mesh is held on the ring member, heat is transferred to the layer causing the second material to partially melt and become tacky is slightly tacky or partially wet; allows the mesh to bond with a partially melted and tacky second material of the layer; and trims the mesh extending beyond the perimeter of the ring member portion wherein the loop member and attached mesh are collapsible by retracting into the lumen of the sheath and expandable to the shape when extended out of the sheath.
所述线的所述形状可以是椭圆形、圆形、泪滴形、正方形、长方形、四边形或多边形中的任一种。The shape of the wire may be any of an oval, a circle, a teardrop, a square, a rectangle, a quadrilateral or a polygon.
环可以具有沿着经过环构件的中心的纵向轴线的第一尺寸和沿着另一轴线的第二尺寸,所述另一轴线垂直于纵向轴线并且还经过环构件的中心。第一尺寸可以长于所述第二尺寸。可选地,所述第一尺寸范围从30至70厘米并且所述第二尺寸范围从15至40厘米。可替选地,所述第一尺寸等于所述第二尺寸。还可替选地,所述第一尺寸小于所述第二尺寸。The ring may have a first dimension along a longitudinal axis passing through the center of the ring member and a second dimension along another axis perpendicular to the longitudinal axis and also passing through the center of the ring member. The first dimension may be longer than the second dimension. Optionally, the first dimension ranges from 30 to 70 centimeters and the second dimension ranges from 15 to 40 centimeters. Alternatively, the first dimension is equal to the second dimension. Also alternatively, the first dimension is smaller than the second dimension.
所述线的所述第一材料可以是镍钛诺、钢或不锈钢中的至少一种。The first material of the wire may be at least one of Nitinol, steel or stainless steel.
所述层的第二材料可以是聚合的。可选地,所述层的第二材料可以是尼龙、PET或聚醚酰胺中的至少一种。The second material of the layer may be polymeric. Optionally, the second material of the layer may be at least one of nylon, PET or polyetheramide.
所述网的第三材料可以是聚合的。可选地,所述网的第三材料可以是尼龙或PET中的至少一种。The third material of the mesh may be polymeric. Optionally, the third material of the mesh may be at least one of nylon or PET.
所述层可以被涂覆在所述成形的线上。The layer may be coated on the shaped wire.
可选地,所述层是中空管,所述成形的线被插入到所述中空管中。Optionally, the layer is a hollow tube into which the shaped wire is inserted.
通过加热所述成形的线,热被转移到所述层的所述第二材料。可选地,使用外部电源来对所述成形的线进行电加热。By heating the shaped wire, heat is transferred to the second material of the layer. Optionally, the shaped wire is electrically heated using an external power source.
在将所述网保持在所述环构件上的同时,通过加热所述环构件来将热转移到所述层的所述第二材料。可选地,通过将所述环构件暴露到一股热空气来加热所述环构件,其中所述热空气具有在120至180℃范围内或者在所述第二材料的熔化温度范围内的温度。Heat is transferred to the second material of the layer by heating the ring member while maintaining the web on the ring member. Optionally, the ring member is heated by exposing the ring member to a stream of hot air, wherein the hot air has a temperature in the range of 120 to 180°C or in the range of the melting temperature of the second material .
可选地,所述层具有范围从0.05mm到0.6mm的厚度。Optionally, the layer has a thickness ranging from 0.05mm to 0.6mm.
在结合后,网可以在环构件的中心处具有袋。After bonding, the mesh may have pockets at the center of the ring members.
本说明书还公开一种将网附接到环构件的方法,所述方法包括以下步骤:以第二材料的层覆盖第一材料的线;操纵所述线和所述层以形成所述环构件,其中所述环构件具有形状并且其中所述环构件具有沿着经过所述环构件的中心的纵向轴线的第一尺寸和沿着另一轴线的第二尺寸,所述另一轴线垂直于所述纵向轴线并且还经过所述环构件的所述中心;将所述环构件放置在基部固定件上以被嵌在基部固定件内的多个磁体至少部分地保持;其中所述保持环构件界定形成在基部固定件内的中空部分,所述中空部分被构造成接纳袋形固定件;将所述网放置在所述环构件上,其中所述网是第三材料的,其中所述网至少部分地覆盖所述环构件的周边和所述中空部分,并且其中所述网的部分延伸超过所述环构件的周边;将所述袋形固定件放置在所述网上,由此件所述网挤压到所述中空部分中;在将所述网保持在所述环构件上的同时,将热转移到所述层使得所述第二材料部分地熔化并变成胶粘的、轻微粘性的或部分湿的;允许所述网沿着所述环构件的周边与所述层的所述部分熔化的第二材料熔合在一起,并且在冷却时形成稳固的结合;以及修整所述网的延伸超过所述环构件的所述周边的所述部分,其中,所述环构件和所附接的网通过缩回到护套的内腔中是可收缩的并且当被延伸出所述护套时可伸展到所述形状。This specification also discloses a method of attaching a mesh to a ring member, the method comprising the steps of: covering a wire of a first material with a layer of a second material; manipulating the wire and the layer to form the ring member , wherein the ring member has a shape and wherein the ring member has a first dimension along a longitudinal axis passing through the center of the ring member and a second dimension along another axis perpendicular to the the longitudinal axis and also passing through the center of the ring member; placing the ring member on the base fixture to be at least partially retained by a plurality of magnets embedded within the base fixture; wherein the retaining ring member defines a hollow portion formed in the base fastener, the hollow portion being configured to receive a pocket fastener; placing the mesh on the ring member, wherein the mesh is of a third material, wherein the mesh is at least partially covering the perimeter of the ring member and the hollow portion, and wherein portions of the mesh extend beyond the perimeter of the ring member; placing the pocket fastener on the mesh, whereby the mesh Extruding into the hollow portion; transferring heat to the layer while retaining the web on the ring member so that the second material partially melts and becomes tacky, slightly tacky or partially wet; allowing the mesh to fuse with the partially melted second material of the layer along the perimeter of the ring member and to form a strong bond upon cooling; and trimming the extent of the mesh the portion beyond the perimeter of the ring member, wherein the ring member and attached mesh are collapsible by retracting into the lumen of the sheath and when extended out of the sheath Stretchable to the shape.
所述环构件的所述形状可以是椭圆形、圆形、泪滴形、正方形、长方形、四边形和多边形中的任一种。The shape of the ring member may be any of oval, circular, teardrop, square, rectangular, quadrilateral and polygonal.
第一尺寸可以长于所述第二尺寸。可选地,所述第一尺寸范围从30至70厘米并且所述第二尺寸范围从15至40厘米。可替选地,所述第一尺寸等于所述第二尺寸。还可替选地,所述第一尺寸小于所述第二尺寸。The first dimension may be longer than the second dimension. Optionally, the first dimension ranges from 30 to 70 centimeters and the second dimension ranges from 15 to 40 centimeters. Alternatively, the first dimension is equal to the second dimension. Also alternatively, the first dimension is smaller than the second dimension.
所述线的所述第一材料可以是镍钛诺、钢或不锈钢。The first material of the wire may be Nitinol, steel or stainless steel.
所述层的第二材料可以是聚合的。可选地,所述层的第二材料是尼龙、聚醚酰胺或PET。The second material of the layer may be polymeric. Optionally, the second material of the layer is nylon, polyetheramide or PET.
所述网的第三材料可以是聚合的。可选地,所述网的第三材料是尼龙或PET。The third material of the mesh may be polymeric. Optionally, the third material of the mesh is nylon or PET.
所述层可以被涂覆在所述线上。The layer may be coated on the wire.
可选地,所述层是中空管,所述线被插入到所述中空管中。Optionally, the layer is a hollow tube into which the wire is inserted.
所述网可以具有与所述环构件的所述形状近似的形状。The mesh may have a shape that approximates the shape of the ring member.
通过加热所述线,热被转移到所述层的所述第二材料。可选地,使用外部电源来对所述线进行电加热。By heating the wire, heat is transferred to the second material of the layer. Optionally, the wire is electrically heated using an external power source.
可选地,在将所述网保持在所述环构件上的同时,通过加热所述环构件来将热转移到所述层的所述第二材料。可选地,通过将所述环构件暴露到一股热空气来加热所述环构件,其中所述热空气具有在120至180℃范围内或者在所述第二材料的熔化温度范围内的温度。Optionally, heat is transferred to the second material of the layer by heating the ring member while maintaining the mesh on the ring member. Optionally, the ring member is heated by exposing the ring member to a stream of hot air, wherein the hot air has a temperature in the range of 120 to 180°C or in the range of the melting temperature of the second material .
可选地,所述层具有范围从0.05mm到0.6mm的厚度。Optionally, the layer has a thickness ranging from 0.05mm to 0.6mm.
在结合后,网可以在环构件的中心处具有袋。After bonding, the mesh may have pockets at the center of the ring members.
本说明书还公开一种将网附接到环构件的方法,该方法包括以下步骤:操纵线以形成成形的线,其中所述线是第一材料的;以第二材料的层覆盖所述成形的线,以形成所述环构件;将所述环构件放置在所述基部固定件上,以被嵌在所述基部固定件中的多个磁体至少部分地保持,其中所述保持环构件在其中围住形成在基部固定件中的中空部分,所述中空部分被构造成接纳袋形固定件;将所述网放置在所述环构件上,其中所述网是第三材料的,其中所述网至少部分地覆盖所述环构件的周边和所述中空部分,并且其中所述网的部分延伸超过所述环构件的周边;将所述袋形固定件放置在所述网上以将所述网挤压到所述中空部分中;在所述网被保持在所述环构件上的同时,将热转移到所述层,使得所述第二材料部分地熔化并变成胶粘的、轻微粘性的或者部分湿的;允许所述网与所述层的部分熔化的第二材料结合;以及修整所述网的延伸超过所述环构件的所述周边的所述部分,其中,所述环构件和所附接的网通过缩回到护套的内腔中是可收缩的并且当被延伸出所述护套时可伸展到所述形状。The present specification also discloses a method of attaching a mesh to a ring member, the method comprising the steps of: manipulating a wire to form a shaped wire, wherein the wire is of a first material; covering the forming with a layer of a second material to form the ring member; placing the ring member on the base fixture to be at least partially retained by a plurality of magnets embedded in the base fixture, wherein the retaining ring member is wherein a hollow portion formed in the base fastener is enclosed, the hollow portion is configured to receive a pocket fastener; the mesh is placed on the ring member, wherein the mesh is of a third material, wherein the the mesh at least partially covers the perimeter of the ring member and the hollow portion, and wherein a portion of the mesh extends beyond the perimeter of the ring member; placing the pocket fastener on the mesh to secure the mesh The mesh is extruded into the hollow; while the mesh is held on the ring member, heat is transferred to the layer, causing the second material to partially melt and become tacky, slightly tacky or partially wet; allowing the mesh to bond with a partially melted second material of the layer; and trimming the portion of the mesh extending beyond the perimeter of the ring member, wherein the ring The member and attached mesh are collapsible by retracting into the lumen of the sheath and expandable to the shape when extended out of the sheath.
将在附图和以下提供的详细描述中更深入地描述本说明书的前述和其它实施例。The foregoing and other embodiments of the present specification will be described in greater detail in the accompanying drawings and the detailed description provided below.
附图说明Description of drawings
本发明的这些和其它特征和优点将被进一步理解,因为当结合附图分析时,通过参考以下详细描述,本发明的这些和其它特征和优点将被更好地理解。These and other features and advantages of the present invention will be further understood because these and other features and advantages of the present invention will be better understood by reference to the following detailed description when analyzed in conjunction with the accompanying drawings.
图1A是根据本说明书的实施例的勒除器环的底透视图;1A is a bottom perspective view of a snare ring according to an embodiment of the present specification;
图1B是图1A的勒除器环的侧透视图;Figure IB is a side perspective view of the snare ring of Figure 1A;
图2是根据实施例的目标物体捕捉和摘取勒除器装置的透视图,还示出了放大部分;2 is a perspective view of a target object capture and extraction snare device, also showing an enlarged portion, according to an embodiment;
图3是管状构件或护套的截面视图,图1A的勒除器环被存储在所述管状构件或护套内并且处于完全缩回或收缩位置;3 is a cross-sectional view of a tubular member or sheath within which the snare ring of FIG. 1A is stored and in a fully retracted or retracted position;
图4是根据本说明书的实施例的勒除器环的带涂层的环构件的截面示意图;4 is a schematic cross-sectional view of a coated ring member of a snare ring according to an embodiment of the present specification;
图5A图示根据本说明书的一些实施例的勒除器环的带涂层的环构件;5A illustrates a coated ring member of a snare ring according to some embodiments of the present specification;
图5B图示根据本说明书的另一实施例的勒除器环带涂层的环构件;5B illustrates a snare cuff-coated ring member according to another embodiment of the present specification;
图6是示出根据本说明书的实施例的处于泪滴形构造的勒除器环的顶透视图,其中网被移除;6 is a top perspective view showing the snare ring in a teardrop configuration with the mesh removed, according to an embodiment of the present specification;
图7A呈现根据实施例的环构件的平面视图,所述环构件在环的近侧端包括紧固件、捆绑件或扣环,诸如至少一个熔接部;7A presents a plan view of a ring member including a fastener, tie or buckle, such as at least one weld, at a proximal end of the ring, according to an embodiment;
图7B示出被粗糙地切割因而具有波纹的或参差不齐的切割表面的紧固件,诸如熔接部;7B shows a fastener, such as a weld, that is rough cut and thus has a corrugated or jagged cut surface;
图7C示出紧固件,诸如熔接部,其被切割成使得其获得平滑的切割表面;Figure 7C shows a fastener, such as a weld, which is cut such that it obtains a smooth cut surface;
图8是实施例中的固定件的透视图,该固定件被用于将网附接、结合或连接到带涂层的环构件;8 is a perspective view of an embodiment of a fastener used to attach, bond or connect a mesh to a coated ring member;
图9图示热结合机制,其中网被结合到带涂层的环构件;Figure 9 illustrates a thermal bonding mechanism in which a mesh is bonded to a coated ring member;
图10图示根据实施例使用激光束来切割被结合到带涂层的环构件的网的延伸部;10 illustrates the use of a laser beam to cut an extension of a mesh bonded to a coated ring member according to an embodiment;
图11是网切割模具的透视图,该网切割模具被用于切割被结合到带涂层的环构件的网的延伸部;Figure 11 is a perspective view of a mesh cutting die used to cut extensions of mesh bonded to a coated ring member;
图12图示沿着带涂层的环构件的近侧长度结合的网的一部分,该部分形成收缩管,其增强带涂层的环构件的近侧端;12 illustrates a portion of the mesh joined along the proximal length of the coated ring member forming a shrink tube that reinforces the proximal end of the coated ring member;
图13是根据本说明书的实施例的图示将网/网状物连接到带涂层的环构件的示例性步骤的流程图。13 is a flow chart illustrating exemplary steps for attaching a mesh/mesh to a coated ring member according to an embodiment of the present specification.
具体实施方式Detailed ways
公开一种用于从人体内摘取物体的外科勒除器或摘取装置。勒除器装置被成在内窥镜内使用,并且可以被用于在相对紧的内腔内摘除相对重的物体,诸如例如,从食道摘取紧实的食团。在讨论的装置中,相对于操作员的手使用术语远侧和近侧。换言之,当在内窥镜或类似装置的工作/服务通道内使用装置时,近侧定向和远侧定向相对于装置的外科医生或操作员,其中近侧位置代表装置的靠近装置的外科医生或操作员的部分,并且远侧位置代表装置的指向患者的远的末端。A surgical snare or extraction device for extracting objects from a human body is disclosed. The snare device is intended for endoscopic use and can be used to remove relatively heavy objects within a relatively tight lumen, such as, for example, a compact bolus from the esophagus. In the devices discussed, the terms distal and proximal are used relative to the operator's hand. In other words, when the device is used within the working/service channel of an endoscope or similar device, the proximal and distal orientations are relative to the surgeon or operator of the device, where the proximal position represents the device's proximity to the surgeon or to the device. The operator's part, and the distal position represents the distal end of the device that points toward the patient.
本说明书涉及多个实施例。提供以下公开以便使得本领域的普通技术人员能够实施本发明。该说明书中使用的语言不应被理解为任一个具体实施例的一般否定或者超出这里所使用的术语的含义而被用于限制权利要求。这里定义的一般原理可以被应用到其它实施例和应用,而不背离本发明是范围和精神。此外,使用的术语和语法是出于描述示例实施例的目的,并且不应被理解成是限制性的。因而,本发明将符合最广泛的范围,涵盖与公开的原理和特征相符的许多替代方案、修改和等同形式。为了清晰起见,不详细描述与本发明的技术领域中已知的技术材料相关的细节,以便不多余地使得本发明不易理解。This specification refers to various embodiments. The following disclosure is provided to enable those of ordinary skill in the art to practice the present invention. The language used in this specification should not be construed as a general negation of any particular embodiment or used to limit the claims beyond the meaning of the terms used herein. The general principles defined herein may be applied to other embodiments and applications without departing from the scope and spirit of the invention. Also, the terminology and syntax used are for the purpose of describing example embodiments and should not be regarded as limiting. Thus, the present invention is to be accorded the broadest scope encompassing many alternatives, modifications and equivalents consistent with the principles and features disclosed. For the purpose of clarity, details related to technical material that is known in the technical fields of the invention are not described in detail so as not to unnecessarily obscure the present invention.
在本申请的说明书和权利要求中,词语“包括”、“包含”和“具有”及其形式中的每一个非必须限制到与该词语相关的列表中的构件。In the specification and claims of this application, each of the words "comprising", "comprising" and "having" and their forms are not necessarily limited to the means in the list associated with that word.
如在这里使用的,不定冠词意味着“至少一个”或“一个或多个”,除非文中清除地规定。As used herein, the indefinite article means "at least one" or "one or more" unless the context clearly dictates otherwise.
应注意的是,根据一些实施例,这里所提到的术语“内窥镜”可以特别地指结肠镜或胃镜,但不限于仅仅结肠镜和胃镜。术语“内窥镜”可以指用于检查身体的中空器官或腔体的内部的任何器械。It should be noted that, according to some embodiments, the term "endoscope" referred to herein may refer in particular to colonoscopes or gastroscopes, but is not limited to colonoscopes and gastroscopes only. The term "endoscope" may refer to any instrument used to examine the interior of a hollow organ or cavity of the body.
图1A和1B分别是勒除器环101的底透视图和侧透视图,而图2和3分别是根据本说明书的实施例的目标物体捕捉和摘取勒除器装置100的透视图和纵向截面视图。现在参考图1A、1B、2和3,勒除器环101包括柔性可延伸的带涂层的环构件105(下文中可互换地还称为“环”),网或网状物110被可分开地、可移除地但牢固地附接或连接到环构件105。环构件105被描述成“带涂层”,因为环105的线是带涂层的或者被结合材料包裹,如以下参考图3所论述的。勒除器装置100进一步包括管形构件或护套115,其具有伸长本体,所述伸长本体具有近侧端115a和远侧端115b以及通道或内腔120,当处于完全收缩或缩回位置中时,内腔120用于在其中可恢复地存储具有带涂层的网或网状物110的带涂层的环构件105,如在图3中描绘的。FIGS. 1A and 1B are a bottom perspective view and a side perspective view, respectively, of the
在一个实施例中,网或网状物110通过工艺形成,所述工艺诸如但不限于,缠绕编织多股聚合材料诸如尼龙或PET(聚对苯二甲酸二乙醇酯)(或者稍后在该说明说中描述的其它聚合物),而管形构件或护套115由绝缘柔性材料制造,所述绝缘柔性材料包括高密度聚乙烯(HDPE)、四氟乙烯(TFE)树脂或聚四氟乙烯(PTFE)聚合物,诸如和根据实施例,网或网状物或网体110的聚合材料具有弹性性能,使得聚合材料可以在机器方向(MD)上被前进、拉伸或伸长最少10%至40%,并且在机器交叉方向(CMD)上被前进、拉伸或伸长最少20%至70%。本领域的普通技术人员应理解的是,这里所用的术语“机器方向”(MD)指材料通过工艺流动的方向,而这里使用是术语“机器交叉方向”(CMD)指与机器方向大体垂直的方向。在各种实施例中,网110具有范围在每平方厘米15个孔和每平方厘米40个孔之间的孔隙率。在一些实施例中,形成网或网状物110的聚合材料的厚度范围在0.05mm和0.3mm之间。可替换地,网110可以是聚合材料的连续膜或网体。此外,在各种实施例中,网、网状物或网体110是带织纹的或不带织纹的。根据实施例,当将网110与带涂层的环构件105结合时,网、网状物或网体110包括袋或垂体145。In one embodiment, the mesh or
护套115具有与其内腔120联通的远侧开口122,通过该远侧开口122,带涂层的环构件105能被部分地或完全地延伸以部署,并且能被部分地或完全地缩回以存储。在一个实施例中,使用运动传递连杆170来实现带涂层的环构件105从护套内腔120内的延伸和缩回,运动传递连杆170通过护套115的近侧开口124连接到带涂层的环构件105的近侧端107。在各种实施例中,运动传递连杆170是适当刚性材料诸如不锈钢的中空管、扭绞线或编织线。当操作员将连杆170从近侧开口124拉出时,带涂层的环构件105被缩回到护套115中,而当操作员推动连杆170到近侧开口124中时,带涂层的环构件105延伸出来超过护套115的远侧开口122。The
如在图2中所示,护套115从把手组件196的远侧端196a向远侧延伸。在一个实施例中,靠近把手组件196的远侧端196a的护套115的长度包括轴应变释放部197。轴应变释放部197覆盖护套115,并且当传递连杆170被前进到护套115中以部署勒除器环时,轴应变释放部197为传递连杆170(如图3所示)提供应变释放。轴应变释放部197确保传递连杆170的平滑移动,以利于勒除器环的正确部署。As shown in FIG. 2 , the
图4是根据本说明书的方面制造的目标物体捕捉和摘取装置带涂层的环构件105的截面示意图。现在参考图1A、1B、2、3和4,在带涂层的环构件105的中心处是直径“d”的线130,其由弹性但耐用且导电的材料构成,所述材料能够被形成为期望的环形状。根据实施例,线130的直径“d”的范围从0.2至0.6厘米。当带涂层的环构件105在管形构件或护套115内被从其收缩或缩回位置(图3)延伸(图1A、1B和2)时,它自动伸展以保持其期望的环形构造,由此提为附接的网或网状物110提供开口。类似地,当缩回到管形构件或护套115中时,带涂层的环构件105沿着附接的网或网状物110收缩并且其被压缩在护套内腔120内。在各种实施例中,线130由编织的钢、金属形状记忆合金诸如镍钛诺或者柔性的任何其它合适材料、热和电的导体制成,并且同时具有充分的弹性以在被部署时维持其期望环形状。4 is a schematic cross-sectional view of a target object capture and extraction device coated
在一个实施例中,线130的期望的展开形状并且因此带涂层的环构件105的期望的展开形状是泪滴形状(如在图示移除了其网或网状物的带涂层的环构件105的图6中所示),而在替代实施例中,期望的展开形状是椭圆形(图1A、1B)、圆形、正方形、长方形、四边形、多边形或任何其它适合形状,这对本领域的普通技术人员而言是显而易见的。参考图1,相对于椭圆或泪滴形状描述的一个实施例中,环具有沿着纵向轴线150经过环的基准中心的第一尺寸L1和沿着大体垂直于纵向轴线150的另一轴线165并且经过环的基准中心155的第二尺寸L2。在各种实施例中,第一尺寸L1大于第二尺寸L2。在一些实施例中,第一尺寸L1等于第二尺寸L2。在其它实施例中,第一尺寸L1小于第二尺寸L2。根据各种实施例,当线130的期望形状是泪滴或椭圆时,第一尺寸L1范围从30至70厘米,并且第二尺寸L2范围从15至40厘米。In one embodiment, the desired deployed shape of the
重新参考图4,根据说明书的方面,线130被层135涂覆或包裹,层135具有厚度“t”并且由聚合材料组成,在一个实施例中,所述聚合材料起“自结合粘结剂”的作用。如这里所使用的,术语“自结合粘结剂”被定义成指这样一种材料,当被施加热或溶剂时,其能被改变(或被部分地熔化),以变得充分胶粘或粘性,使得当冷却时它将与另一聚合材料和/或金属形成稳固结合。“自结合粘结剂”在网和环的接触区域中将网结合到环,并且在粘结剂已经冷却时提供可靠连接。为了本说明书的目的,胶粘被定义成具有轻微粘性质量或者是部分潮湿的或者是不完全干的。当被加热到低于它们的分解温度或燃点温度时,聚合材料变成具有充分胶粘性或粘结性质的热塑性塑料,以结合到类似表面或不类似表面,诸如金属。聚合材料的示例包括聚烯烃、PET(聚乙烯对苯二酸酯)、聚氨酯、聚降冰片烯、聚醚、聚丙烯酸酯、聚酰胺(聚醚嵌段酰胺,还称为聚醚酰胺)、聚硅氧烷、聚醚酰胺、聚醚酯、反式聚异戊二烯、聚甲基丙烯酸甲酯(PMMA)、交联反式聚辛烯、交联聚乙烯、无机-有机杂化聚合物、具有聚乙烯和的共聚物共混物、苯乙烯-丁二烯共聚物、聚氨酯-丁二烯共聚物、聚己内酯或低聚己内酯共聚物、聚乳酸(PLLA)或聚丙交酯(PL/DLA)共聚物,PLLA-聚乙醇酸(PGA)共聚物和光交联聚合物。Referring back to FIG. 4, in accordance with aspects of the specification, the
在一个实施例中,层135的聚合材料是尼龙或聚醚酰胺。在一个实施例中,通过使用传统方法诸如挤出、包覆成型或浸渍,以聚合材料诸如聚醚酰胺涂覆线130来形成层135。在另一实施例中,层135是聚合物材料诸如聚醚酰胺的中空管,线130被插入到聚合物材料诸如聚醚酰胺中使得管像护套一样包裹或覆盖线130。在一些实施例中,中空管形式的层135具有范围在0.3mm和1.0mm之间的内经和范围在0.5mm和1.50mm之间的外径。在各种实施例中,聚合材料诸如聚醚酰胺的涂层或中空管形式的层135具有从0.05mm到0.6mm范围的厚度“t”。In one embodiment, the polymeric material of
图5A示出勒除器环101a的实施例,其(涂层或中空管形式的)中层135连续包裹或覆盖线130。在替代实施例中,如图5B中的勒除器环101b所示,层135被分段成多个区段,使得线130的多个部分130’保持裸露或者没有涂层或中空管(层135)。当勒除器环101正被延伸或缩回时,该不连续的或分段的层135提供网110更多的柔性来变形。根据一方面,(涂层或中空管形式的)层135具有明亮的颜色,诸如但不限于,蓝色、绿色、红色等。在环101与体液流体连同时,诸如在内窥镜程序期间,层135的明亮的颜色能够实现环边界的提高的可视性。FIG. 5A shows an embodiment of a snare ring 101a with a middle layer 135 (in the form of a coating or hollow tube) continuously wrapping or covering the
在本说明书的勒除器环101的制造或组装过程期间,在一个实施例中,线130首先被弯曲或弯折成期望的环形状并且此后被用层135涂覆或包裹。在替代实施例中,然而,线130首先被用层135涂覆或包裹,并且此后被弯曲或弯折成期望的环形状。在一些实施例中,已经被弯曲或弯折成期望的环形状的线130包括在环105的近侧端处的紧固件、捆绑件或扣环140,如图7A中所示。在各种实施例中,紧固件、捆绑件或扣环140包括至少一个熔接部、海波管、至少一个夹子或者其它固定件,以将近侧臂141、142保持在一起,通过将线130弯曲成环150而获得所述近侧臂141、142。然而,在线130需要被包裹在中空管135内的实施例中,紧固件、捆绑件或扣环140干涉。因此,在一个实施例中,紧固件140,诸如至少一个熔接部,被切割而不损坏线130,同时还在切割处维持平滑区域或表面。被不正确或粗糙地切割的紧固件或捆绑件,诸如熔接部,具有波纹的或参差不齐的表面143,如图7B所示,而正确切割的紧固件或捆绑件,诸如熔接部,获得平滑的表面143’,如图7C所示。在各种实施例中,线130和/或中空管135的内部通道可以被涂覆有干润滑剂,以减小在将线130放入到中空管135内的过程中的摩擦。干润滑剂的非限制性示例包括PTFE(聚四氟乙烯)粉末、模可离(McLube)、硅油等。然而,在一些实施例中,线130被弯曲或弯折成期望的环形状而不具有熔接部。在这样的实施例中,容易完成将线130放入到中空管135内。During the manufacturing or assembly process of the
下文同时参看图1A、1B、2-4、5A和5B,以及图7A、7B、7C和8-12,根据本说明书的实施例,为了将网或网状物110附接到带涂层的环构件105,网或网状物110被放置或保持在带涂层的环构件105上,并且线130被加热。网110的形状近似于带涂层的环构件105的形状。此外,网110的尺寸被选择成使得网110的部分沿着网110的边缘延伸超过下方的带涂层的环构件105的周边。在一个实施例中,当被放置在带涂层的环构件105上时,网110具有刻意的松弛。在网110被附接或连接到带涂层的环构件105后,所述松弛优选地在带涂层的环构件105的中线155处引起袋145的变形。1A, 1B, 2-4, 5A, and 5B, and FIGS. 7A, 7B, 7C, and 8-12, in accordance with embodiments of the present specification, for attaching a net or mesh 110 to a
图8示出基部固定件175的实施例,基部固定件175被用于将网110附接到带涂层的环构件105。在上表面177处,基部固定件175包括环保持区域176,其近似于带涂层的环构件105的形状。在一个实施例中,环保持区域176包括多个磁体178,一旦带涂层的环构件105被放置在环保持区域上,所述多个磁体稳固紧地将带涂层的环构件105保持在位。环保持区域176在期间限定中空部分并且在其内形成基部固定件175。中空部分被构造成在其中接纳袋形固定件180。FIG. 8 shows an embodiment of a base fastener 175 that is used to attach the
对于组装,带涂层的环构件105被放置在环保持区域176上方,从而带涂层的环构件105被多个磁体178稳固地保持。在一个实施例中,多个磁体178被嵌在基部紧固件175内,以在近似沿着由环保持区域176限定的周边或边界处。接着,网110被放置在被保持的带涂层的环构件105上。此时,网110覆盖带涂层的环构件105,使得网110的沿着其边缘的部分延伸超过下方的带涂层的环构件105的周边。袋形固定件180然后被放置在网110的位于中空部分上方的部分上,从而促使、挤压或压迫网110进入到中空部分中。该挤压网110以填充中空部分导致袋145的变形(如图1B所示)。根据一方面,网110至少被袋形固定件180的重量保持在位。多个引导销孔182允许对应的引导销插入其中,以保持和/或维持网110、环105和袋形固定件180一起对齐。For assembly, the
为了将网110连接到带涂层的环构件105,线130被加热到适当温度,使聚合材料诸如尼龙或聚醚酰胺的层135部分地熔化、软化并且变得足够胶粘或粘性而不燃烧或分解。所述适当的温度至少取决于正被使用的具体聚合材料。在一个实施例中,通过使用外部电路或电源来电加热线130,热被转移到层135。在替代实施例中,在使上方的网110被稳固地保持在其上的同时,通过使带涂层的环构件105经受热空气的冲击,热被转移到层135。在各种实施例中,热空气具有在120至180℃范围内或者在结合材料的熔化温度范围内的温度。在又另一实施例中,如图9所示,通过使用高温熨烫热挤压185(或者对本领域普通技术人员显而易见的任何其它热源)沿着网110的位于带涂层的环构件105的周边上方的边缘对网110进行高温熨烫、热挤压或者热熔接,热被转移到层135。结果,多个网110的多个聚合线股(诸如,例如尼龙或PET线股)被胶粘或粘性层135结合到环线,由此在冷却时形成稳固结合。To connect the
当将网110与层135(因此与带涂层的环构件105)稳固结合时,如在图10中所示,网110的延伸超过带涂层的环构件105的周边的部分186被切割或修整以移除松端或部分186(还称为“延伸部分”)。在一个实施例中,如图10所示,激光束187被用于切割或修整延伸部分186。在替代实施例中,如图11所示,网切割模具190被使用。如所示的,附接、结合或熔合的网110和带涂层的环构件105组件(下文中还称为“结合组件”)被放置并对齐在引导或对齐销192和194之间。切割模具190近似环构件105的形状并且具有中空部分195,当模具195在“结合组件”上挤压时,中空部分195包围形成的袋145。在“结合组件”上压迫或推压模具190导致对延伸部分186的切割或修整。当切割模具190在“结合组件”上被挤压以实现模具190关于“结合组件”正确对齐时,配对孔192’接纳对齐销192,由此精确切割或修整延伸部分186。在又进一步的实施例中,超声熔接被用于切割或修整延伸部分186。经由超声熔接生成热,由此熔化网的区域并且切割它们。When the
如在图12中所示,根据实施例,网110的在环105的近侧长度198上延伸的部分被熔化或者与层135的沿着近侧长度198的对应部分结合。在切割或修整延伸部分186后(如图10和11中所示),近侧长度198保持网110的熔化部分在其上形成收缩管,由此保持在一起并且为近侧臂141、142(在图7A中可见)提供足够的增强。As shown in FIG. 12 , according to an embodiment, the portion of the
根据本说明书的替代实施例,网110被直接结合到线130,避免了对层135的需要。在这样的实施例中,网110被使用以下方法结合到线130:粘结剂,其随后被弄干;紫外线、激光或热熔接;热熔;或者,本领域的普通技术人员已知的任何其它方法。在一个实施例中,在固化过程中使用UV(紫外线)固化粘结剂将网110直接粘合到线130(不需要层135),其中高强度紫外线或辐射被用于加速粘结剂的固化或干燥(通过紫外线辐射来曝光或照射粘结剂)。UV固化粘结剂的示例是由Henkel销售的牌粘结剂。According to an alternative embodiment of the present specification,
在使用中,其中压紧有柔性或可延伸的带涂层的环构件105的管形构件或护套115被插入穿过内窥镜的工作或服务通道以定位成靠近体腔内的目标物体,诸如息肉、被切断的人体组织、外来物体或者压紧的食团。当将要执行目标物体的捕捉时,带涂层的环构件105被从管形构件或护套105延伸出来,并且在过程中,自动伸展,由此为附接的网110并且因此为袋145提供开口。在一个实施例中,当目标物体被捕捉在网110中时,带涂层的环构件105被部分地缩回以将目标物体稳固在网110内。在另一实施例中,一旦目标物体被捕捉在网110中,就将摘取装置和目标物体从患者移除,而不将带涂层的环构件105缩回到护套115中。在一个实施例中,袋145的存在进一步有助于稳固地保持目标物体。In use, the tubular member or
图13是根据本说明书的各种实施例的图示形成带涂层的环构件和将网或网状物附接、结合或连接到带涂层的环构件的方法的示例性步骤的流程图。在步骤1310,获得线。线具有直径“d”并且是编织钢、不锈钢、镍钛诺或本领域的普通技术人员已知的任何其形状记忆合金。在一个实施例中,在布置1315a,线被涂覆有厚度为“t”的聚合材料层或被包裹在聚合材料层中,所述聚合材料诸如但不限于尼龙或聚醚酰胺。通过用聚合材料涂覆线或将线插在聚合材料的中空管中来形成所述层。在步骤1320a,涂覆有聚合材料层或被聚合材料层包裹的线然后被操纵诸如被弯曲或弯折成期望形状和尺寸的环,以形成带涂层的环构件。在另一实施例中,在步骤1315b,线首先被操纵诸如被弯曲或弯折成期望形状和尺寸的环。此后,在步骤1320,形成环的线被以聚合材料层涂覆或者被包裹在聚合材料层中,以形成带涂层的环构件。13 is a flow chart illustrating exemplary steps of a method of forming a coated loop member and attaching, bonding or connecting a mesh or mesh to the coated loop member according to various embodiments of the present specification . At step 1310, lines are obtained. The wire has a diameter "d" and is braided steel, stainless steel, Nitinol, or any other shape memory alloy known to those of ordinary skill in the art. In one embodiment, at arrangement 1315a, the wire is coated with or wrapped in a layer of polymeric material having a thickness "t", such as, but not limited to, nylon or polyetheramide. The layer is formed by coating the wire with a polymeric material or inserting the wire in a hollow tube of polymeric material. At step 1320a, the wire coated or wrapped with a layer of polymeric material is then manipulated, such as bent or bent into a loop of a desired shape and size, to form a coated loop member. In another embodiment, at step 1315b, the wire is first manipulated such as being bent or bent into a loop of the desired shape and size. Thereafter, at step 1320, the loop-forming wire is coated with or wrapped in a layer of polymeric material to form a coated loop member.
在一些实施例中,在步骤1315b,首先被弯曲或弯折成期望的环形状的线包括在环的近侧端的紧固件、捆绑件或扣环,以将通过线的弯曲获得的近侧臂保持在一起。在各种实施例中,紧固件、捆绑件或扣环包括至少一个熔接部、海波管、至少一个夹子或本领域的普通技术人员显而易见的任何其它固定件。在这样的实施例中,在用聚合材料层(在一个实施例中,诸如中空管)涂覆或包裹线以形成带涂层的环构件之前,紧固件,诸如至少一个熔接部,首先被切割或者移除。In some embodiments, at step 1315b, the wire, which is first bent or bent into the desired loop shape, includes fasteners, binders or buckles at the proximal end of the loop to convert the proximal end obtained by bending the wire Arms stay together. In various embodiments, the fastener, tie, or buckle includes at least one weld, hypotube, at least one clip, or any other fastener apparent to one of ordinary skill in the art. In such an embodiment, before coating or wrapping the wire with a layer of polymeric material (such as a hollow tube in one embodiment) to form the coated loop member, the fastener, such as at least one weld, is first be cut or removed.
在各种实施例中,环的期望的形状是椭圆形、圆形、泪滴形、正方形、长方形、四边形或多边形。在一个实施例中,环具有沿着经过带涂层的环构件的中心的纵向轴线的第一尺寸和沿着另一轴线的第二尺寸,所述另一轴线垂直于纵向轴线并且还经过带涂层的环构件的中心。在各种实施例中,第一尺寸长于第二尺寸。在一些实施例中,第一尺寸等于第二尺寸。在其它实施例中,第一尺寸小于第二尺寸。应理解的是,带涂层的环构件通过使用步骤1315a和1320a形成或可替选地使用步骤1315b和1320b形成。In various embodiments, the desired shape of the ring is an oval, circle, teardrop, square, rectangle, quadrilateral, or polygon. In one embodiment, the ring has a first dimension along a longitudinal axis passing through the center of the coated ring member and a second dimension along another axis perpendicular to the longitudinal axis and also passing through the belt The center of the coated ring member. In various embodiments, the first dimension is longer than the second dimension. In some embodiments, the first dimension is equal to the second dimension. In other embodiments, the first dimension is smaller than the second dimension. It will be appreciated that the coated ring member is formed using steps 1315a and 1320a or alternatively using steps 1315b and 1320b.
接着,在步骤1325,获得聚合材料的网、网体或网状物,所述聚合材料诸如但不限于尼龙、PET。网的形状近似于带涂层的环构件的形状,并且网的尺寸稍大于带涂层的环构件的尺寸。在步骤1330,带涂层的环构件被放置在基部固定件上,所述基部固定件具有多个磁体以将带涂层的环构件保持在位。此后,网或网状物被放置并保持在带涂层的环构件上,使得网的沿着其边缘的部分延伸超过带涂层的环构件的周边。在一些实施例中,网部分地覆盖环构件的周边。在其它实施例中,网完全地覆盖环构件的周边。在一个实施例中,使用袋形成固定件,覆盖带涂层的环构件的中心的网的一部分被挤压或压迫以位于被限定在基部固定件内的中空部内(从而通过至少袋形固定件的重量将网保持在位)。这使得当网被放置在带涂层的环构件上的同时,网具有刻意的松弛。在网被连接到带涂层的环构件之后,所述松弛导致袋在带涂层的环构件的中心处的变形。Next, at step 1325, a mesh, mesh or mesh of polymeric material such as but not limited to nylon, PET is obtained. The shape of the mesh approximated the shape of the coated ring members, and the dimensions of the mesh were slightly larger than the dimensions of the coated ring members. At step 1330, the coated ring member is placed on a base fixture having a plurality of magnets to hold the coated ring member in place. Thereafter, the mesh or mesh is placed and held on the coated ring member such that portions of the mesh along its edges extend beyond the perimeter of the coated ring member. In some embodiments, the mesh partially covers the perimeter of the ring member. In other embodiments, the mesh completely covers the perimeter of the ring member. In one embodiment, a pocket is used to form the fastener, and a portion of the mesh covering the center of the coated ring member is squeezed or pressed to be located within a hollow defined in the base fastener (thereby passing through at least the pocket fastener the weight to keep the net in place). This allows for deliberate slack in the mesh while it is being placed on the coated ring member. After the mesh is attached to the coated ring member, the relaxation results in deformation of the bag at the center of the coated ring member.
现在,在步骤1335,热被转移到聚合材料层。在一个实施例中,带涂层的环构件的线被加热袋适当温度,使聚合材料层部分地熔化、软化并且变得足够胶粘,轻微粘性或者部分湿的,而不燃烧或分解。使用方法将热转移到聚合材料层,所述方法诸如但不限于,使用外部电路或电源电加热下方的线,将带涂层的环构件曝露到热空气流(在热空气流吹过网和带涂层的环时放置在环上的网被稳固地保持在位),沿着网的位于带涂层的环构件的周边上的边界在网上施加应用高温熨烫、热挤压,或者对本领域的普通技术人员显而易见的任何其它方法。结果,在步骤1340,位于带涂层的环构件的周边的表面上的网的多个线股与胶粘或粘性层熔合或被粘接到胶粘或粘性层,并且在冷却时与带涂层的环构件稳固地结合。最后,在步骤1345,使用激光束、超声熔接或网切割模具将结合的网的延伸超过带涂层的环构件的周边的部分切割或修整。这确保不存在延伸超过带涂层的环构件的松端或线股,因为这可能使得当在内窥镜手术中使用时网撕破和/或损坏周围的组织。Now, at step 1335, heat is transferred to the layer of polymeric material. In one embodiment, the wire of the coated ring member is heated by the bag to a suitable temperature so that the layer of polymeric material partially melts, softens and becomes sufficiently tacky, slightly tacky or partially wet without burning or decomposing. Heat is transferred to the layer of polymeric material using methods such as, but not limited to, using an external circuit or power source to electrically heat the underlying wire, exposing the coated ring member to a stream of hot air (while the stream of hot air blows over the mesh and When the coated loop is placed on the loop, the net is firmly held in place), applying a high temperature ironing, hot pressing, or Any other method apparent to one of ordinary skill in the art. As a result, at step 1340, the plurality of strands of the web located on the surface of the perimeter of the coated ring member are fused or bonded to the adhesive or tacky layer and are coated with the tape as it cools. The ring members of the layers are firmly bonded. Finally, at step 1345, the portion of the bonded mesh extending beyond the perimeter of the coated ring member is cut or trimmed using a laser beam, ultrasonic welding, or mesh cutting die. This ensures that there are no loose ends or strands extending beyond the coated ring member, as this could allow the mesh to tear and/or damage the surrounding tissue when used in endoscopic procedures.
上述示例仅仅是本说明书的方法和系统的许多应用的说明。尽管这里仅仅描述了本发明的一些实施例,但是应理解的是,本发明可以许多其它具体形式实施,而非背离本发明的精神或范围。因此,所提供的示例和实施例应被认为是说明性的而非限制性的,并且可以在所附权利要求的范围内对本发明进行修改。The above examples are merely illustrative of the many applications of the methods and systems of this specification. Although only a few embodiments of the present invention have been described herein, it should be understood that the present invention may be embodied in many other specific forms without departing from the spirit or scope of the invention. Accordingly, the examples and embodiments provided are to be regarded as illustrative and not restrictive, and the invention may be modified within the scope of the appended claims.
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EP4427687A2 (en) | 2024-09-11 |
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